Guidelines for Control of Cosmetic Products in Malaysia

Guidelines for Control of Cosmetic Products in Malaysia

January 2008 (rev01)

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TABLE OF CONTENTS: 1. Introduction

1.1. What is cosmetic product notification

2. The regulation of cosmetic products 2.1. Introduction

3. Legal aspects of cosmetic control 3.1. Director of Pharmaceutical Services (DPS) 3.2. Definitions 3.2.1. Cosmetic Product 3.2.2. Manufacturer 3.2.3. Primary Assembler 3.2.4. Secondary Assembler 3.2.5. Product Variant 3.3. Legislation covering the manufacturer

4. Who should notify the authority 4.1. Criteria of person who notifies local authority 4.2. Responsibility of person who notifies local authority

5. Notification Procedure 5.1. Document which must accompany notification form 5.2. Language 5.3. Privacy markings 5.4. Product variant 5.5. Multiple manufacturer 5.6. Processing fees 5.7. Notification validity period 5.8. Manufacture or importation of product 5.9. Changes in notification particulars

6. Post-Market surveillance 6.1 Product Information File (PIF) 6.1.1 Language 6.1.2 Updating 6.2 Safety assessment of cosmetic product

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7. Cosmetic ingredients 8. Labeling requirements 9. Cosmetic claims 10. Good Manufacturing Practice (GMP) 11. Authorization for manufacture, import or wholesale

11.1. Manufacturing Authorization 11.2. Import Authorization 11.3. Wholesale Authorization 12. Products for export only or In-transit 13. Test market sampling or aesthetic studies and In-house evaluation 13.1 Test market sampling or aesthetic studies 13.1. In-house evaluation 14. Reporting of adverse events 15. Product Recall 15.1 Degree and level of recall 15.2 Decision on the degree and level of recall 15.3 Record keeping 16. Cancellation of Notification and Authorization 17. Withdrawal 18. Penalty 19. Cosmetic Advertising Code 20. Appendices

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1. INTRODUCTION

This guideline was prepared by the Cosmetic Technical Working Group (CTWG), comprising of the National Pharmaceutical Control Bureau (NPCB) and representatives from the cosmetic industry. The Guidelines for Control of Cosmetic Products in Malaysia is prepared in accordance to the ASEAN Cosmetic Directive.

The primary goal of the CTWG is to implement an efficient regulatory control system without compromising consumer safety by incorporating the requirements of the ASEAN Cosmetics Directives. Ensuring safety, quality and claimed benefits of cosmetic products are the fundamental principles of cosmetics product control.

1.1 What is cosmetic product notification

This notification process will allow the NPCB to gather adequate information on the cosmetic products that are placed in the local market.

Under the Control of Drugs and Cosmetics (amendment) Regulations 2007, the company or person responsible for placing a cosmetic product in the local market must notify the Director of Pharmaceutical Services (DPS) through National Pharmaceutical Control Bureau (NPCB) prior to product manufacture or importation.

It is an offence for anyone to manufacture or import a cosmetic product without prior notification to the DPS.

2. THE REGULATION OF COSMETIC PRODUCTS

2.1 Introduction The Government regulates the manufacture, sale and importation of cosmetic products in the following ways:

? By requiring that all cosmetic products be notified before manufacture, sale, supply by wholesale and import

? By requiring the company or person carrying out the notification be registered Please refer Annex 1, part 1 ? Membership Registration for Quest 2 system.

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? By requiring the manufacture, importation and wholesale be authorized ? By conducting post-market surveillance

3. LEGAL ASPECTS OF COSMETIC CONTROL

3.1 Director of Pharmaceutical Services (DPS) The authority responsible for the regulation of cosmetic products lies with the DPS. National Pharmaceutical Control Bureau (NPCB) is a secretariat to the DPS which is responsible for the cosmetic product notification process.

3.2 Definitions The following definitions are based on the ASEAN Cosmetic Directives:

3.2.1 Cosmetic Product A cosmetic product shall mean "any substance or preparation intended to be placed in contact with various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition".

Please refer to Annex 1, part 2 - Illustrative list by category of cosmetic product

3.2.2 Manufacturer A manufacturer is a company which is engaged in any process carried out in the course of making the cosmetic products. The manufacturing process includes all operations of purchase of starting materials, bulk intermediates and products, formulation and production (such as grinding, mixing, encapsulation and / or packaging), quality control, release, storage and distribution of cosmetic products and the related controls.

3.2.3 Primary Assembler A primary assembler is a company which is engaged in a process of enclosing the product in a primary/intermediate container which is labeled or to be labeled before the product is sold or supplied in it.

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